Regulatory Strategy
Accelerate Your Regulatory Approvals in India
eteraflex connects delivers end-to-end regulatory affairs services across the entire product lifecycle — from early preclinical pathway design to final market authorization and post-market compliance. With 150+ successful regulatory clearances, deep CDSCO expertise, and proven accelerated timelines, we help global pharmaceutical, biotech, and medical device companies navigate India’s regulatory landscape with confidence.
Regulatory Excellence Across the Full Lifecycle
eteraflex provides a unified regulatory framework for pharmaceuticals, biologics, and medical devices, combining scientific, strategic, and compliance-driven regulatory planning.
We support the full lifecycle — preclinical → clinical → submission → approval → post-market compliance — ensuring predictable, audit-ready, and timely approvals across all regulatory pathways.
Our Regulatory Capabilities
Pharmaceutical, Biologics & Medical Device Programs
Our regulatory programs deliver full-cycle strategy and submission support through:
Strategic Regulatory Development
Specialized regulatory leadership covering early development through market entry.
Clinical Trial Regulatory Support
End-to-end regulatory guidance across trial initiation, execution, and study closeout.
Medical Device Regulatory Expertise
Tailored regulatory pathways, CERs, PMCF planning, and accelerated device licensing.
Authority Engagement & Representation
Regulatory meetings, advisory committee preparation, and strategic communication.
Our services span full lifecycle regulatory strategy, dossier development, compliance oversight, and final submissions.
How We Deliver
eteraflex ensures seamless regulatory execution through a structured and transparent framework:
- Preclinical & Pathway Strategy: Competitive landscape review, pathway optimization, and positioning guidance.
- Regulatory Feasibility: Risk–benefit evaluation, timeline modeling, and approval strategy planning.
- Dossier Preparation: Documentation development, quality review, submission assembly, and tracking.
- CDSCO Coordination: Query anticipation, rapid resolution workflows, and approval optimization.
- Lifecycle Compliance: Amendments, safety reporting, and post-market requirement management.
Our integrated approach enables faster approvals, fewer queries, and complete regulatory predictability.
Technology & Quality
Regulatory Intelligence Platform — Built for Speed and Compliance
eteraflex leverages proprietary regulatory frameworks and digital workflow systems to simplify and accelerate every submission process.
Technology Platform Integration
- Standardized dossier templates
- Real-time submission tracking
- Automated quality review workflows
- Documentation accuracy & completeness checks
- Predictive approval timeline modeling
Quality & Compliance Excellence
- Inspection Readiness: Zero critical findings across 150+ submissions
- Risk-Based Compliance: Continuous oversight & regulatory alignment
- Automated CAPA Systems: Root-cause analysis & corrective pathways
- Regulatory Reliability: High approval predictability
- Continuous Improvement: Ongoing documentation optimization
A Trusted Regulatory Network Across India
Our regulatory network spans government agencies, ethics committees, notified bodies, medical institutions, and device validation partners — enabling efficient submissions, faster review cycles, and consistent compliance across all programs.
Clinical Trial Regulatory Support
Protocol review, CDSCO submissions, ethics coordination, amendments, safety reporting, and post-study regulatory completion.
Medical Device Regulatory Expertise
CER development, PMCF planning, device classification strategy, accelerated licensing (6–8 weeks), and full quality system development.
Regulatory Authority Engagement
Authority meetings, advisory committee representation, query responses, regulatory intelligence, and strategic guidance through commercialization.
